Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery

Surgery--Complications Clinical Trial

Official title:

Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery Can Prevent Post-thyroidectomy Hypoparathyroidism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04193332
• Other study ID #: H19010211
• Status: Recruiting
• Phase: N/A
• Start date: August 16, 2019
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2022
• Source: Rigshospitalet, Denmark
• Contact: Eva Lykke, MD
• Phone: +45 35454799
• Email: eva.lykke[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this ongoing randomized controlled trial is to examine whether the use of intra-operative NIR(near infrared) camera can reduce the number of patients who experience transient or persistent hypoparathyroidism after total thyroidectomy and completion thyroidectomy, both in malignant and benign thyroid disease.

Description:

Patients admitted to total thyroidectomy or completion thyroidectomy is ramdomized to:

1. Intervention: NIR optic imaging assisted identification of the parathyroid glands during thyroidectomy using parathyroid gland autofluorescence.

2. Control: Conventional thyroidectomy and parathyroid identification by the surgeon.

Measurements:

PTH and ionized-Ca blood samples are collected preoperatively, within 12 hours postoperatively and at 1-, 3-, 9- and 12-months follow-up.

Anticipated 214 patients are included, all of which participate in 3 months follow-up. Only patients with persistent hypoparathyroidism at this point continue til maximum 12 months follow-up.

An interim analysis will be conducted when inclusion of anticipated 128 patients and 3 months follow-up is reached.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to understand patient information and to give written informed consent

• Patients admitted to either total thyroidectomy og completion thyroidectomy, both benign and malign.

Exclusion Criteria:

• Not able to understand patient information and to give written informed consent

• Previous parathyroid surgery or other parathyroid decease

• Age under 18

Related Conditions & MeSH terms

• Hypocalcemia
• Hypoparathyroidism
• Hypoparathyroidism Postprocedural
• Surgery--Complications

Intervention

Device:
• NIR optical imaging camera
NIR optical imaging assisted identification of parathyroid glands during thyroid surgery using parathyroid gland autofluorescense

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
Denmark	Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark	Køge

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Cluster for molecular imaging, Denmark, Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

Abbaci M, De Leeuw F, Breuskin I, Casiraghi O, Lakhdar AB, Ghanem W, Laplace-Builhé C, Hartl D. Parathyroid gland management using optical technologies during thyroidectomy or parathyroidectomy: A systematic review. Oral Oncol. 2018 Dec;87:186-196. doi: 10.1016/j.oraloncology.2018.11.011. Epub 2018 Nov 16. — View Citation

Benmiloud F, Rebaudet S, Varoquaux A, Penaranda G, Bannier M, Denizot A. Impact of autofluorescence-based identification of parathyroids during total thyroidectomy on postoperative hypocalcemia: a before and after controlled study. Surgery. 2018 Jan;163(1):23-30. doi: 10.1016/j.surg.2017.06.022. Epub 2017 Nov 6. — View Citation

Dip F, Falco J, Verna S, Prunello M, Loccisano M, Quadri P, White K, Rosenthal R. Randomized Controlled Trial Comparing White Light with Near-Infrared Autofluorescence for Parathyroid Gland Identification During Total Thyroidectomy. J Am Coll Surg. 2019 May;228(5):744-751. doi: 10.1016/j.jamcollsurg.2018.12.044. Epub 2019 Jan 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative hypoparathyroidism	Hypoparathyroidism defined as: PTH < 1,6 pmol/L and based on European Society of Endocrinology Clinical Guideline	24 months-follow-up
Secondary	Postoperative hypocalcemia	Hypocalcemia defined as: ionized Calcium < 1,15 mmol/L	12 months follow-up
Secondary	Time	Duration of surgery	Immediately after surgery
Secondary	Parathyroidglands identified by NIR light	Number of identified by NIR light vs. white light	During surgery